Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Dose Effect of Limicol on (LDL)-Cholesterol Levels

This study has been completed.
Sponsor:
Collaborator:
BioFortis
Information provided by (Responsible Party):
Lescuyer Laboratory
ClinicalTrials.gov Identifier:
NCT01354340
First received: May 12, 2011
Last updated: April 18, 2012
Last verified: April 2012

May 12, 2011
April 18, 2012
April 2011
December 2011   (final data collection date for primary outcome measure)
Change from Baseline in blood LDL-cholesterol levels after 4 weeks of supplementation (limicol double dose group versus placebo group) [ Time Frame: 4 weeks after baseline ] [ Designated as safety issue: No ]
Change from Baseline in blood LDL-cholesterol levels at 4 months (limicol simple dose group versus limicol double dose group) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01354340 on ClinicalTrials.gov Archive Site
  • Change from Baseline in blood LDL-cholesterol levels after 4 weeks of supplementation (limicol double dose group versus limicol simple dose group) [ Time Frame: 4 weeks after baseline ] [ Designated as safety issue: No ]
  • Change from Baseline in blood total cholesterol, HDL-cholesterol and TAG levels after 4 weeks of supplementation (limicol double dose group versus limicol simple dose group versus placebo group) [ Time Frame: 4 weeks after baseline ] [ Designated as safety issue: No ]
  • Change from Baseline in blood LDL-cholesterol, total cholesterol, HDL-cholesterol and TAG levels 4 weeks after end of supplementation (limicol double dose group versus limicol simple dose group versus placebo group) [ Time Frame: 8 weeks after baseline ] [ Designated as safety issue: No ]
  • Change from Baseline in CK, LDH and other safety biomarkers levels after 4 weeks of supplementation (limicol double dose group versus placebo group versus placebo group) [ Time Frame: 4 weeks after baseline ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Dose Effect of Limicol on (LDL)-Cholesterol Levels
Dose Effect of Limicol on (LDL)-Cholesterol Levels in Moderate Hypercholesterolaemia

The principal objective of this study is to investigate the dose-effect of the Limicol food supplement on LDL-cholesterol level in moderate hypercholesterolaemia subjects.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Hypercholesterolaemia
  • Dietary Supplement: Limicol
    3 tablets (Limicol) + 3 tablets (Placebo) / day during 1 month and follow-up 1 month without treatment
  • Dietary Supplement: Limicol
    6 tablets (Limicol) / day during 1 month and follow-up 1 month without treatment
  • Other: Placebo
    6 tablets (Placebo) / day during 1 month and follow-up 1 month without treatment
  • Experimental: Limicol simple dose
    Intervention: Dietary Supplement: Limicol
  • Experimental: Limicol double doses
    Intervention: Dietary Supplement: Limicol
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Barrat E, Zaïr Y, Sirvent P, Chauveau P, Maudet C, Housez B, Derbord E, Lescuyer JF, Bard JM, Cazaubiel M, Peltier SL. Effect on LDL-cholesterol of a large dose of a dietary supplement with plant extracts in subjects with untreated moderate hypercholesterolaemia: a randomised, double-blind, placebo-controlled study. Eur J Nutr. 2013 Dec;52(8):1843-52. doi: 10.1007/s00394-012-0486-2. Epub 2012 Dec 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
January 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • About 18 to 65 years (inclusive).
  • Subject has a stable weight for at least three months before the start of the study.
  • Subject able and willing to comply with the protocol and agreeing to give their consent in writing.
  • Subject affiliated with a social security scheme.
  • Subject willing to be included in the national register of volunteers who lend themselves to biomedical research.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01354340
2011-A00145-36
No
Lescuyer Laboratory
Lescuyer Laboratory
BioFortis
Study Director: Sebastien Peltier, PhD Lescuyer Laboratory
Lescuyer Laboratory
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP